F
EN-64
english
General provisions
EN-65
english
F
General provisions
Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity test
IEC 60601 test level Compliance level
Electromagnetic environment - guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient/burst IEC
61000-4-4
±2 kV for power
supply lines
±1 kV for input/out-
put lines
±2 kV for power
supply lines
±1 kV for input/out-
put lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5 ±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Note: Power plug type is 2-pin.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
(>95% dip in U
T
) for
0.5 cycle
40% U
T
(60% dip in
U
T
) for 5 cycles
70% U
T
(30% dip in
U
T
) for 25 cycles
<5% U
T
(>95% dip in
U
T
) for 5 sec.
(>95% dip in U
T
) for
0.5 cycle
40% U
T
(60% dip in
U
T
) for 5 cycles
70% U
T
(30% dip in
U
T
) for 25 cycles
<5% U
T
(>95% dip
in U
T
) for 5 sec.
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the device requires continued operation during
power mains interruptions, it is recommended
that the device is powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment..
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should ensure that it is used in such an environment.
Emissions test
Compliance Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The device uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/Flicker
emissions IEC 61000-3-3
Complies
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